510(k) · Cleared

Cleared

Depuy Motech Moss Miami Spinal Systems

K982511510(k) TraditionalCleared Sep 14, 199856-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Sep 14, 1998 as substantially equivalent to K933881 (Depuy, Inc., 1994) and 8 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1995. 413 later devices descend from it.

Decided: Sep 14, 1998
Review: 56 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 10

Its longest line of descent runs back 2 generations to K951116 (1995). 9 ancestors in all, the oldest K933881 (1994). 413 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
1 generation backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
This deviceK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
Descendant · cites it directly · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
Descendant · 2 generations on · 180 of its ownK071890 Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · Recalled
Descendant · 3 generations on · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
Descendant · 3 generations on · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
Descendant · 4 generations on · 150 of its ownK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled

Showing 5 of 413 descendants. See all descendants

Descendants cleared per year

2003high 41 (2023) · low 1 (2003)2026

Most influential descendants

Showing 5 of 413 · See all

K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · cites it directly410descendants
K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · 2 generations on180descendants
K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009 · 3 generations on170descendants
K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010 · 3 generations on168descendants
K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · 4 generations on150descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K951116	Acromed Pedicle Screw	Acromed Corp.	1995	—
−1	K963639	Acromed Pedicle Screw	Acromed Corp.	1996	—
0 (this device)	K982511	Depuy Motech Moss Miami Spinal Systems	Depuy, Inc.	1998	—
+1	K030383	Modification to Moss Miami Spinal System Polyaxial Screws	Depuyacromed	2003	—
+2	K071890	Zodiac 4.0 Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	2007	1
+3	K093077	Zodiac Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	2009	—
+3	K100685	Zodiac Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	2010	—
+4	K133221	Arsenal Spinal Fixation System	Alphatec Spine, Inc.	2014	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	2	0
1996	3	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	2	0
2006	1	0
2007	8	0
2008	9	0
2009	9	0
2010	6	0
2011	2	0
2012	11	0
2013	18	0
2014	19	0
2015	22	0
2016	20	0
2017	23	0
2018	28	0
2019	19	0
2020	23	0
2021	19	0
2022	27	0
2023	41	0
2024	39	0
2025	37	0
2026	28	0

FIG. 1 — Lineage of K982511, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (10)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K933881	Depuy Motech Moss-Miami Spinal System Summary page 1 …osis, and pedicle screws have not been classified DEVICE PRODUCT CODE: 87 KWQ, KWP, MNH e SUBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INT…	Depuy, Inc.	1994	—
*	K950697	Depuy Motech Moss Miami Spinal System - Pedicle Fixation Summary page 1 …pedicle screws have not been classified DEVICE PRODUCT CODE: 87 KWQ, KWP, MNH e SUBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE…	Depuy Motech	1995	—
*	K953915	Moss Miami Spinal System (Anterior Use) Summary page 1 …screws have not been classified DEVICE PRODUCT CODE: 87 KWQ, KWP, MNH e SUBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE: The MO…	Depuy, Inc.	1996	—
*	K955348	Titanium Moss Miami Spinal System Summary page 1 …ve not been classified DEVICE PRODUCT CODE: 87 KWQ, KWP, MNH e SUBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE: The MOSS MIAMI…	Depuy, Inc.	1996	—
*	K964024	Depuy Motech Titanium Moss Miami Spinal System Summary page 1 …en classified DEVICE PRODUCT CODE: 87 KWQ, KWP, MNH e SUBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE: The MOSS MIAMI Sstem is…	Depuy, Inc.	1997	—
Kept off the family tree	K944736	FDA’s K944736 is VSP (Variable Screw Placement) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Acromed Corp.	1995	—
*	K951116	Acromed Pedicle Screw Summary page 1 …KWQ, KWP, MNH e SUBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE: The MOSS MIAMI Sstem is available jn cither Stainless Steel or…	Acromed Corp.	1995	—
*	K951657	VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S), Spine Plate… Summary page 1 …MNH e SUBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE: The MOSS MIAMI Sstem is available jn cither Stainless Steel or Titanium.…	Acromed Corp.	1995	—
*	K952236	Isola System Summary page 1 …UBSTANTIALLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE: The MOSS MIAMI Sstem is available jn cither Stainless Steel or Titanium. The foll…	Acromed Corp.	1996	—
*	K963639	Acromed Pedicle Screw Summary page 1 …LLY \| EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal Systems: ) K933881, K950697, K953915, K955348, K964024 AcroMed VSP & ISOLA: K544736, K951116, K951657, K952236, K963639 DEVICE DESCRIPTION AND INTENDED USE: The MOSS MIAMI Sstem is available jn cither Stainless Steel or Titanium. The following com…	Acromed Corp.	1996	—

Also cleared against K933881: 14 other devices →

What descends from it? (413)

See all 413

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030383	Modification to Moss Miami Spinal System Polyaxial Screws	Depuyacromed	2003	410
K120291	OP Spine System	OrthoPediatrics Corp.	2012	138
K160926	F1 MPS Modular Pedicle Screw System	Degen Medical	2016	1
K071743	Pillar Pedicle Screw System	The 4th Column, LLC	2007	0
K070295	Single Planar Multi Axial (Spma) Pedicle Screw System	Trinity Orthopedics, LLC	2007	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
None of the 9 ancestors has a recall.
Of its descendants, K030383 (Depuyacromed, 2003) has gone furthest, with 410 descendants of its own.
14 other devices also cite its predicate K933881.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

What is it indicated for?

The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by…

Read the full statement (148 words)

The MOSS Miami Spinal System is intended for non-cervical use in the spine.

When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982511: Depuy Motech Moss Miami Spinal Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982511

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026